CA2941829C - Ondansetron extended release solid dosage forms for treating either nausea, vomiting or diarrhea symptoms - Google Patents

Ondansetron extended release solid dosage forms for treating either nausea, vomiting or diarrhea symptoms Download PDF

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Publication number
CA2941829C
CA2941829C CA2941829A CA2941829A CA2941829C CA 2941829 C CA2941829 C CA 2941829C CA 2941829 A CA2941829 A CA 2941829A CA 2941829 A CA2941829 A CA 2941829A CA 2941829 C CA2941829 C CA 2941829C
Authority
CA
Canada
Prior art keywords
ondansetron
pharmaceutically acceptable
amount
tablet
salt
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CA2941829A
Other languages
English (en)
French (fr)
Other versions
CA2941829A1 (en
Inventor
Reza Fathi
Gilead RADAY
Guy GOLDBERG
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Redhill Biopharma Ltd
Original Assignee
Redhill Biopharma Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=54067752&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2941829(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Redhill Biopharma Ltd filed Critical Redhill Biopharma Ltd
Publication of CA2941829A1 publication Critical patent/CA2941829A1/en
Application granted granted Critical
Publication of CA2941829C publication Critical patent/CA2941829C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Hospice & Palliative Care (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Otolaryngology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CA2941829A 2014-03-11 2015-03-11 Ondansetron extended release solid dosage forms for treating either nausea, vomiting or diarrhea symptoms Active CA2941829C (en)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201461951092P 2014-03-11 2014-03-11
US201461951074P 2014-03-11 2014-03-11
US201461951112P 2014-03-11 2014-03-11
US61/951,074 2014-03-11
US61/951,092 2014-03-11
US61/951,112 2014-03-11
US201462040136P 2014-08-21 2014-08-21
US62/040,136 2014-08-21
PCT/IB2015/000997 WO2015136377A2 (en) 2014-03-11 2015-03-11 Ondansetron extended release solid dosage forms for treating either nausea, vomiting or diarrhea symptoms

Publications (2)

Publication Number Publication Date
CA2941829A1 CA2941829A1 (en) 2015-09-17
CA2941829C true CA2941829C (en) 2021-11-02

Family

ID=54067752

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2941829A Active CA2941829C (en) 2014-03-11 2015-03-11 Ondansetron extended release solid dosage forms for treating either nausea, vomiting or diarrhea symptoms

Country Status (17)

Country Link
US (3) US9675588B2 (pt)
EP (1) EP3116500B1 (pt)
JP (1) JP6461186B2 (pt)
KR (1) KR20160132057A (pt)
CN (1) CN106456611B (pt)
AU (1) AU2015228545B2 (pt)
BR (1) BR112016020877B1 (pt)
CA (1) CA2941829C (pt)
CL (1) CL2016002251A1 (pt)
IL (1) IL247698B (pt)
MX (1) MX2016011734A (pt)
PH (1) PH12016501756B1 (pt)
RU (1) RU2706708C2 (pt)
SG (1) SG11201607511WA (pt)
UA (1) UA121209C2 (pt)
WO (1) WO2015136377A2 (pt)
ZA (1) ZA201606276B (pt)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2016272089B2 (en) 2015-06-03 2021-02-18 Triastek, Inc. Dosage forms and use thereof
EP3573602A4 (en) * 2017-01-26 2020-09-16 Triastek, Inc. DOSAGE FORMS OF CONTROLLED RELEASE AT SPECIFIC GASTROINTESTINAL SITES
JP7315383B2 (ja) * 2019-06-27 2023-07-26 株式会社Ｓｃｒｅｅｎホールディングス インクジェット用水性組成物及び固体製剤
WO2023102491A1 (en) * 2021-12-01 2023-06-08 Invea Therapeutics, Inc. Methods for treating gastrointestinal inflammatory disease

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US5419917A (en) * 1994-02-14 1995-05-30 Andrx Pharmaceuticals, Inc. Controlled release hydrogel formulation
BE1011045A3 (fr) 1997-03-14 1999-04-06 Ucb Sa Compositions pharmaceutiques pour la liberation controlee de substances actives.
US6090411A (en) * 1998-03-09 2000-07-18 Temple University Monolithic tablet for controlled drug release
US6733789B1 (en) 1999-01-21 2004-05-11 Biovail Laboratories, Inc. Multiparticulate bisoprolol formulation
CA2393601A1 (en) 1999-12-09 2001-06-14 Alza Corporation Antiviral medication
US6936275B2 (en) 1999-12-20 2005-08-30 Scolr, Inc. Amino acid modulated extended release dosage form
WO2003024427A1 (en) 1999-12-20 2003-03-27 Temple University Of The Commonwealth System Of Higher Education Tableted oral extended release dosage form
US20020044962A1 (en) 2000-06-06 2002-04-18 Cherukuri S. Rao Encapsulation products for controlled or extended release
US6500457B1 (en) 2000-08-14 2002-12-31 Peirce Management, Llc Oral pharmaceutical dosage forms for pulsatile delivery of an antiarrhythmic agent
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US20050131045A1 (en) 2002-04-30 2005-06-16 Judith Aronhime Novel crystal forms of ondansetron, processes for their preparation, pharmaceutical, compositions containing the novel forms and methods for treating nausea using them
US7704527B2 (en) 2002-10-25 2010-04-27 Collegium Pharmaceutical, Inc. Modified release compositions of milnacipran
DE602004005814T2 (de) 2003-01-13 2008-01-10 Dynogen Pharmaceuticals Inc., Waltham Verfahren zur behandlung von übelkeit, erbrechen, würgereiz oder jede kombination daraus
JP4674162B2 (ja) * 2003-11-14 2011-04-20 千寿製薬株式会社 アミノグリコシド系抗生物質およびブロムフェナクを含有する水溶液製剤
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Also Published As

Publication number Publication date
AU2015228545A1 (en) 2016-09-22
IL247698B (en) 2020-08-31
IL247698A0 (en) 2016-11-30
US20150258029A1 (en) 2015-09-17
WO2015136377A2 (en) 2015-09-17
UA121209C2 (uk) 2020-04-27
US9675588B2 (en) 2017-06-13
EP3116500A4 (en) 2017-10-25
JP2017507966A (ja) 2017-03-23
KR20160132057A (ko) 2016-11-16
US10668050B2 (en) 2020-06-02
SG11201607511WA (en) 2016-10-28
AU2015228545B2 (en) 2020-03-12
CA2941829A1 (en) 2015-09-17
PH12016501756A1 (en) 2016-11-07
US20200253933A1 (en) 2020-08-13
RU2016139474A3 (pt) 2018-10-26
CL2016002251A1 (es) 2017-11-03
EP3116500B1 (en) 2023-09-13
BR112016020877A8 (pt) 2021-07-20
PH12016501756B1 (en) 2016-11-07
WO2015136377A3 (en) 2016-01-14
JP6461186B2 (ja) 2019-01-30
RU2706708C2 (ru) 2019-11-20
MX2016011734A (es) 2017-02-13
BR112016020877A2 (pt) 2017-08-15
EP3116500A2 (en) 2017-01-18
RU2016139474A (ru) 2018-04-11
ZA201606276B (en) 2019-04-24
BR112016020877B1 (pt) 2022-11-29
CN106456611B (zh) 2021-07-20
US20170258768A1 (en) 2017-09-14
CN106456611A (zh) 2017-02-22

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